| CTRI Number |
CTRI/2026/02/102772 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a Comparative Clinical study To Evaluate The Efficacy of Guduchi Tail Matrabasti As Addo On Therapy With Antigout Drug In Gout. |
|
Scientific Title of Study
|
A Comparative Clinical Trial To Evaluate The Efficacy of Guduchi Tail Matrabasti As Add On Therapy With Antigout Drug In Gout. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIPALI ARVIND KUNDALWAL |
| Designation |
PhD scholar |
| Affiliation |
Assistant professor |
| Address |
Shri saptashringi ayurved college,Kamal nagar,Hirawadi,Nashik
Siddhakala ayurvedic college Sangamner, Ahilyanagar
Ahmadnagar
MAHARASHTRA
422003
India |
| Phone |
9860187857 |
| Fax |
|
| Email |
beldardipali30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjusha Sunil More |
| Designation |
Professor & HOD Panchakarma |
| Affiliation |
professor |
| Address |
OPD of panchakarma,Shri Saptashringi Ayurved College,Kamal nagar ,Hirawadi,Nashik
Shri Saptashringi Ayurved College,Hirawadi,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422766836 |
| Fax |
|
| Email |
manjushasunilmore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjusha Sunil More |
| Designation |
Professor & HOD Panchakarma |
| Affiliation |
Professor & HOD Panchakarma |
| Address |
opd of panchakarma,department of panchakarma,Shri Saptashringi Ayurved College,Hirawadi,Nashik
Shri Saptashringi Ayurved College,Hirawadi,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422766836 |
| Fax |
|
| Email |
manjushasunilmore@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DIPALI KUNDALWAL |
| Address |
Shri Saptashringi Ayurved College,Hirawadi,Nashik,422003 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr manjusha More |
Shri Saptashringi ayurvedic college,Hirawadi, Nashik |
Opd and Ipd of panchakarma department
Nashik
MAHARASHTRA |
9422766836
manjushasunilmore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| institutional ethical committee shri saptashringi ayurved college,nashik |
Approved |
| Institutional ethical committee shri Saptashringi ayurvedic college, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M258||Other specified joint disorders. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः Pradhan Karma | (Procedure Reference: Charak siddhisthan 4/52, Procedure details: 60 ml of guduchi tail Matrabasti at morning before meal for 15 days of duly prepared patients )
(1) Medicine Name: Guduchi Tail , Reference: Charak chikitsasthan 29/121, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age:20 – 65years.
2. Sex:Both male and female.
3. Socio Economic status: All
4. Patients of Gout presenting features as per text such as swelling, pain, stiffness,
tenderness, Discolouration of skin.
|
|
| ExclusionCriteria |
| Details |
Age below 20 and above 65 years.
Arthropathy other than Gout.Leprosy,SLE,Sarvang shoth,TB,Renal disease.
Pregnancy and lactating mother. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the uric acid level in gout after giving Guduchi Tail Matrabasti with Antigout Drug allopurinol for 15 days |
0th day before trial, 15th day after trial and 30th day on day of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 30-10-2029 and end date provided 30-10-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a clinical trial to evaluate the Efficacy of Guduchi Tail Matrabasti as add on therapy with Antigout Drug in gout with the help of subjective and objective cliteria and specific test with the help of case record form |